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Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02203877
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : August 12, 2016
Information provided by (Responsible Party):
Biosearch S.A.

Brief Summary:
To evaluate the effect of the consumption of Lactobacillus fermentum CECT5716 on mastitis incidence.

Condition or disease Intervention/treatment Phase
Mastitis Dietary Supplement: Lactobacillus fermentum CECT5716 Dietary Supplement: Maltodextrin Not Applicable

Detailed Description:
Previous studies have demonstrated that L. fermentum CECT5716, a probiotic strain previously isolated from breast milk, can be used as an effective treatment of mastitis and painful breastfeeding by reducing pathogen counts in breast milk. This is a randomized double blinded controlled study to evaluate the effect of L.fermentum CECT5716 on mastitis incidence and Staphylococcus load in breast milk. Women will be recruited 1-6 days after child birth and distributed into two groups: Probiotic group receiving 1 capsule/day containing L.fermentum 3x109cfu; Control group receiving 1 placebo capsule/day containing maltodextrin. The intervention period is 16 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Intervention Study, Randomized, Double-blind, Parallel Group to Evaluate the Effect of Lactobacillus Fermentum CECT5716 Consumption on the Incidence of Mastitis
Study Start Date : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Placebo Comparator: Maltodextrin
1 capsule/day for 16 weeks
Dietary Supplement: Maltodextrin
Intervention with a daily capsule containing maltodextrin as placebo

Experimental: Lactobacillus fermentum CECT5716
L.fermentum 3,00E+09cfu/day. 1 capsule/day for 16 weeks
Dietary Supplement: Lactobacillus fermentum CECT5716
Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.

Primary Outcome Measures :
  1. incidence of mastitis [ Time Frame: up to 16 weeks ]
    mastitis was defined as at least two out of the three breast symptoms (pain, redness, lump) and at least one of fever or flu-like symptoms (shivering, hot sweats or aches)

Secondary Outcome Measures :
  1. evaluation of breast pain [ Time Frame: at times 0, 4, 8, 12 and 16 weeks ]
    For pain evaluation a score from 1 (no pain) to 10 (extremely pain)

Other Outcome Measures:
  1. microbiota breast milk [ Time Frame: at time 0 and 16 weeks ]
    DNA will be extracted from breast milk samples. Staphylococcus genus, Streptococcus and Lactobacillus will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.

  2. fecal microbiota of infants [ Time Frame: at 0 and 16 weeks ]
    DNA will be extracted from infant´s feces samples. Lactobacillus, bifidobacterium, clostridium, bacteroides will be evaluated by qPCR with specific probes designed to quantify these bacterial genus.

  3. growth of infants [ Time Frame: at 0 and 16 weeeks ]
    Weight, length and head circumference will be measured in infants at the beginning and at 16 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy women between 18 and 40 years with development of normal pregnancy Birth between 37 and 42 weeks of gestation. Women who have received antibiotic treatment between 48 hours before and 48 hours after childbirth (one dose is sufficient for inclusion regardless of the type of antibiotic).

Childbirth took place 1-7 days prior to recruitment.. With firm intention to breast-feed their children for at least 16 weeks..

Exclusion Criteria:

  • - Mammary pathologies that hinder or preclude breastfeeding.
  • Low expectation of adherence to the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02203877

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Hospital Virgen de las Nieves
Granada, Spain
Sponsors and Collaborators
Biosearch S.A.
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Study Chair: Juristo Fonollá, PhD Biosearch S.A.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biosearch S.A. Identifier: NCT02203877    
Other Study ID Numbers: P032
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: July 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases